CBT for Anxiety in Children With Autism

Anxiety Clinical Trial

Official title:

Neural Mechanisms of CBT for Anxiety in Children With Autism: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02725619
• Other study ID #: 1211011144B
• Secondary ID: 1R01HD083881-01A
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: October 12, 2022

Study information

• Verified date: November 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized controlled trial of Cognitive Behavioral Therapy (CBT) versus Psychoeducation and Supportive Therapy (PST) in children with Autism Spectrum Disorder and moderate to severe anxiety. The study will utilize fMRI to identify CBT-invoked changes in levels of activity/functional connectivity within the neural circuits involved in emotion regulation and social perception. Matched typically developing children without autism and/or anxiety will be scanned twice, 16 weeks apart, to enable interpretation of treatment-evoked change relative to normative development.

Description:

Anxiety is among the most common concerns in children with autism spectrum disorder (ASD) who seek mental health services, causing suffering and family stress and exacerbating social disability. Cognitive-Behavioral Therapy (CBT) is a promising treatment for anxiety in children with high-functioning ASD, but the neural mechanisms supporting response to this treatment have not been studied. The neural-systems-level targets of CBT for anxiety in children with ASD will be investigated by evaluating brain indices of socio-emotional functioning with functional magnetic resonance imaging (fMRI) before and after treatment. CBT teaches emotion regulation skills, such as cognitive reappraisal, followed by behavioral exposure to anxiety-provoking situations. It is hypothesized that CBT aimed at the reduction of anxiety will enhance the neural circuitry that subserves the experience and regulation of emotions. This is a randomized controlled trial of CBT vs. Psychoeducation and Supportive Therapy (PST) in 100 school-age children with high-functioning ASD and moderate to severe anxiety. In addition, 50 matched typically-developing (TD) children will be scanned twice with a 16-week interval to enable interpretation of change in brain function in children with ASD after CBT vs. PST relative to TD children. CBT for anxiety will be provided using a structured manual that has been modified for children with ASD by increasing parental participation and addressing the role of core ASD symptoms in the experience and expression of anxiety. Subjects will be comprehensively characterized with regard to ASD diagnosis, IQ, adaptive behavior, and comorbid psychopathology. Functional MRI will be collected as the subjects perform tasks involving emotion regulation, emotional face perception, biological motion perception, and resting state.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 12, 2022
• Est. primary completion date: April 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

Inclusion Criteria:

• Boys and girls, ages 8 to 14 inclusive

• Diagnosis of autism spectrum disorder

• Diagnosis of anxiety disorder and clinically significant level of anxiety

• Full scale IQ and Verbal IQ > 70

• Unmedicated or on stable medication with no planned changes for duration of study

• able to meet MRI safety (e.g., no metal medical implants) and data quality requirements (e.g., able to keep head still during scanning)

Exclusion Criteria:

• Presence of a known serious medical condition that would interfere with participation in the study

• Present of a current psychiatric disorder that requires immediate clinical attention

• A previous adequate trial of CBT for anxiety within the past 2 years.

Note: This study will also recruit healthy volunteers (typically developing children without past or current mental health concerns).

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Behavioral:
• CBT

• PST

Locations

Country	Name	City	State
United States	Yale Child Study Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Sukhodolsky DG, Bloch MH, Panza KE, Reichow B. Cognitive-behavioral therapy for anxiety in children with high-functioning autism: a meta-analysis. Pediatrics. 2013 Nov;132(5):e1341-50. doi: 10.1542/peds.2013-1193. Epub 2013 Oct 28. — View Citation

Sukhodolsky DG, Scahill L, Gadow KD, Arnold LE, Aman MG, McDougle CJ, McCracken JT, Tierney E, Williams White S, Lecavalier L, Vitiello B. Parent-rated anxiety symptoms in children with pervasive developmental disorders: frequency and association with cor — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	blood oxygenation level dependent signal (BOLD) during perception of biological versus scrambled motion.	During a Functional Magnetic Resonance Imaging (fMRI), participants will perform the biological motion perception task. This task involves viewing coherent and scrambled point-light displays of biological motion created from motion capture data. The coherent motion displays feature an adult performing easily recognizable movements, such as playing pat-a-cake. The scrambled motion animations were created by randomly selecting 16 points from the biological motion displays and plotting their trajectories on a black background.	change from baseline (week 0) at endpoint (week 16)
Primary	Pediatric Anxiety Rating Scale (PARS)	The PARS is a 50-item semi-structures interview of anxiety that will be conducted by an expert clinician. Endorsed symptoms are rated using 0-5 severity scale on 7 dimensions and a sum of scores for 5 of 7 dimensions constitute the total PARS score.	change from baseline (week 0) at midpoint (week 8)
Primary	Pediatric Anxiety Rating Scale (PARS)	The PARS is a 50-item semi-structures interview of anxiety that will be conducted by an expert clinician. Endorsed symptoms are rated using 0-5 severity scale on 7 dimensions and a sum of scores for 5 of 7 dimensions constitute the total PARS score.	change from baseline (week 0) at endpoint (week 16)
Primary	Clinical Global Impression - Improvement (CGI-I) scale	The CGI-I reflects the IE's assessment of overall change of the target symptoms from baseline on a scale from very much improved (score of 1) through no change (score of 4) to very much worse (score of 7). By convention, ratings of very much improved (score of 1) and much improved (score of 2) define positive response.	change from baseline (week 0) at midpoint (week 8)
Primary	Clinical Global Impression - Improvement (CGI-I) scale	The CGI-I reflects the IE's assessment of overall change of the target symptoms from baseline on a scale from very much improved (score of 1) through no change (score of 4) to very much worse (score of 7). By convention, ratings of very much improved (score of 1) and much improved (score of 2) define positive response.	change from baseline (week 0) at endpoint (week 16)
Primary	blood oxygenation level dependent signal (BOLD) during down-regulation versus passive viewing of affective images.	During a Functional Magnetic Resonance Imaging (fMRI), subjects will view neutral and affect-inducing pictures selected to be appropriate for children. During the emotion regulation task, subjects are asked to either simply look at the pictures or to down-regulate their emotional reaction to the picture.	change from baseline (week 0) at endpoint (week 16)
Secondary	blood oxygenation level dependent signal (BOLD) during emotional face perception task	During a Functional Magnetic Resonance Imaging (fMRI), subjects will complete the emotional face perception task. This task involves subjects being asked to view and match emotional faces and geometrical shapes. During "match emotion" blocks, participants view a trio of angry, fearful, or neutral faces and match emotional expression of one of two faces to the target face.	change from baseline (week 0) at endpoint (week 16)